Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorDeciphera Pharmaceuticals, LLC

About this trial

The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl estradiol/levonorgestrel) in healthy female participants. This study will last approximately 35 days.

Eligibility criteria

Qualifiers

Participants are in good general health, as required by the protocol and as determined by Principal Investigator.

Body mass index (BMI) from greater than or equal to (≥) 18.5 to less than or equal to ≤ 30 kilogram per square meter (kg/m²).

Adequate organ function, blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Disqualifiers

History or presence of clinically significant diseases of the neurological, dermatological, renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease as determined by Principal Investigator.

Unwilling or unable to comply with the requirements of the protocol.

Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.

Trial design

Treatments tested in this trial

  • Vimseltinib
  • Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators